Articular DiseaseSIBERIENCT05007405
Spectrum of Bacterial Infections in Rheumatology
An observational study of Articular Disease, run by Hôpital NOVO at 1 site in France.
Trial summary
Retrospective study of patients with a proved non-tuberculous osteoarticular infection (OAI) diagnosed in a rheumatology department during the years 2010-2020. The objectives are : To describe sites, type of micro-organism, clinical data, origin of infection, therapeutic modalities et outcome To compare OAI of urinary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Articular Disease
- What is being tested?
- Groups/Cohortes
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020
Who may be able to join
- Subject aged 18 years and over at the time of diagnosis
- Osteoarticular infection (septic arthritis, spondylodiscitis), by a bacterium or a fungus, proven by a bacteriological sample in situ or in the blood by positive blood culture (with an unequivocal clinical, biological and imaging feature),
- Diagnosed between 01/01/2010 and 12/31/2020 (11 years)
- Hospitalization in the rheumatology department of CH René Dubos, Pontoise
Who cannot join
- Bacterial infection due to the following germs: mycobacteria, brucella, Borrelia
- Early infection on joint prosthesis
- Peripheral osteomyelitis
- Osteoarticular infection without bacteriological proof
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Rheumatology, Hospital René Dubos, Pontoise
Pontoise, 95300
About this study
Official title: Spectrum of Bacterial Infections in Rheumatology and the Role of Urinary Tract Infection
Retrospective study of patients with a proved non-tuberculous osteoarticular infection (OAI) diagnosed in a rheumatology department during the years 2010-2020. The objectives are :
- To describe sites, type of micro-organism, clinical data, origin of infection, therapeutic modalities et outcome
- To compare OAI of urinary origin with those with another origin
Read the detailed description
This retrospective study will be conducted on medical files. Patients will be mainly selected on :
- A proved osteoarticular infection (OAI) diagnosed in the department of rheumatology of the René Dubos hospital from 1° January 2010 to 31 December 2020.
- Adult patients 18 year's old or older
- Infection proved by positive culture in the osteoarticular site and/or blood (with typical clinical and imaging features)
The followed OAI are not included :
- Infection on prosthetic joint, materiel ; post-operative OAI ; osteomyelitis
- Brucellosis ; Lyme disease
Patients are selected from the codification of the hospitalization ; medical files are reviewed by the investigators.
OAI of urinary origin is defined either by the same micro-organism in urine and osteo-articular sample (or blood) or a bacteria in the osteo-articular sample in conjunction with : urologic pathology, recurrent urinary tract infection, urologic surgery, antibiotic therapy.
- Characteristics of three populations will be compared :
- - OAI of urinary origin
- - OAI of another origin (skin, etc)
- - OAI without known origin Characteristics include : gender, age, risk factors, site of osteo-articular infection, type of micro-organism, type of positive sample(s), blood cultures, urinary cultures, duration of symptoms, site of primary infection and/or type of contamination, biological results, echocardiography, imaging results, type of treatment (medical, surgical), outcome, duration of hospitalization, intensive unit care stay, death at hospital.
- Conditions
- Articular Disease
- Being tested
- Groups/Cohortes
- Keywords
- Osteoarticular infection, Bacteria, Urinary tract infections
- Medical subject headings
- Joint Diseases, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Groups/CohortesOther
Also called Osteoarticular infections
Retrospective study on medical file of patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020
| Study group | Role | What they receive |
|---|---|---|
| Osteoarticular infections | Retrospective study on medical file of patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020 Receives: Other: Groups/Cohortes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the spectrum of osteoarticular infections in adult, in a rheumatology department
The purpose of this database is to describe the spectrum of osteoarticular infections in adults, non-tuberculosis germs, in a rheumatology department of a CHG during the 2010s
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Prevalence of urinary origin in osteoarticular infections in adults, compared with other origins
The second purpose of this database is to identify the characteristics of osteo-articular infections of urinary origin
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start12 Feb 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Articular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard Pertuiset, Dr, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007405
- Sponsor's protocol ID
- CHRD 1820
- Acronym
- SIBERIE
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30.
PubMed 28366221Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR, Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015 Sep 15;61(6):e26-46. doi: 10.1093/cid/civ482. Epub 2015 Jul 29.
PubMed 26229122
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum of Bacterial Infections in Rheumatology and the Role of Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05007405
- Acronym / sponsor ID
- SIBERIE / CHRD 1820
- Conditions
- Articular Disease
- Keywords
- Osteoarticular infection, Bacteria, Urinary tract infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective study of patients with a proved non-tuberculous osteoarticular infection (OAI) diagnosed in a rheumatology department during the years 2010-2020. The objectives are :
- To describe sites, type of micro-organism, clinical data, origin of infection, therapeutic modalities et outcome
- To compare OAI of urinary origin with those with another origin
Detailed description
This retrospective study will be conducted on medical files. Patients will be mainly selected on :
- A proved osteoarticular infection (OAI) diagnosed in the department of rheumatology of the René Dubos hospital from 1° January 2010 to 31 December 2020.
- Adult patients 18 year's old or older
- Infection proved by positive culture in the osteoarticular site and/or blood (with typical clinical and imaging features)
The followed OAI are not included :
- Infection on prosthetic joint, materiel ; post-operative OAI ; osteomyelitis
- Brucellosis ; Lyme disease
Patients are selected from the codification of the hospitalization ; medical files are reviewed by the investigators.
OAI of urinary origin is defined either by the same micro-organism in urine and osteo-articular sample (or blood) or a bacteria in the osteo-articular sample in conjunction with : urologic pathology, recurrent urinary tract infection, urologic surgery, antibiotic therapy.
- Characteristics of three populations will be compared :
- - OAI of urinary origin
- - OAI of another origin (skin, etc)
- - OAI without known origin Characteristics include : gender, age, risk factors, site of osteo-articular infection, type of micro-organism, type of positive sample(s), blood cultures, urinary cultures, duration of symptoms, site of primary infection and/or type of contamination, biological results, echocardiography, imaging results, type of treatment (medical, surgical), outcome, duration of hospitalization, intensive unit care stay, death at hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoarticular infections | – | Other: Groups/CohortesRetrospective study on medical file of patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020
Key inclusion criteria (4 listed)
- Subject aged 18 years and over at the time of diagnosis
- Osteoarticular infection (septic arthritis, spondylodiscitis), by a bacterium or a fungus, proven by a bacteriological sample in situ or in the blood by positive blood culture (with an unequivocal clinical, biological and imaging feature),
- Diagnosed between 01/01/2010 and 12/31/2020 (11 years)
- Hospitalization in the rheumatology department of CH René Dubos, Pontoise
Key exclusion criteria (4 listed)
- Bacterial infection due to the following germs: mycobacteria, brucella, Borrelia
- Early infection on joint prosthesis
- Peripheral osteomyelitis
- Osteoarticular infection without bacteriological proof
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Groups/CohortesAlso: Osteoarticular infectionsRetrospective study on medical file of patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020 | Other | Osteoarticular infections |
Primary outcome
Identification of the spectrum of osteoarticular infections in adult, in a rheumatology department
Time frame: Through study completion, an average of 1 year
The purpose of this database is to describe the spectrum of osteoarticular infections in adults, non-tuberculosis germs, in a rheumatology department of a CHG during the 2010s
1 secondary outcome
Prevalence of urinary origin in osteoarticular infections in adults, compared with other origins
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 28366221Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30.
- Background: PubMed 26229122Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR, Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015 Sep 15;61(6):e26-46. doi: 10.1093/cid/civ482. Epub 2015 Jul 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edouard Pertuiset, Dr principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Articular Disease, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the spectrum of osteoarticular infections in adult, in a rheumatology department (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.